Medtronic Extended MMT-441ARecalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
All models of Medtronic Extended (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Extended infusion set is a single-use set for delivering fluid under the skin. Most of the 838 reports describe the adhesive failing and the set coming off early, and some mention leaks. A few describe high blood sugar after the set came loose. The reports include 72 injuries and no deaths. Reports from the past year number 498, up from 52 in the year before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,162
- Deaths reported
- 1
- Injuries reported
- 106
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,162 adverse event reports that list this exact device (DI 05705244022805), received between Jun 21, 2022 and Sep 30, 2026 — classified as 1 death, 106 injuries, 1,055 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (732 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond732
- Premature Separation608
- Leak/Splash132
- Adverse Event Without Identified Device or Use Problem72
- Detachment of Device or Device Component67
- Use of Incorrect Control/Treatment Settings45
- Fluid/Blood Leak23
- Material Twisted/Bent22
Patient problems
- No Clinical Signs, Symptoms or Conditions992
- Hyperglycemia110
- Elevated Ketones/ Diabetic Ketoacidosis19
- Skin Inflammation/ Irritation17
- Hypoglycemia12
- Hemorrhage/Blood Loss/Bleeding5
- Skin Infection4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 1,162 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948219 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948202 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking on (b)(6) 2026 due to perspiration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947289 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking on (b)(6) 2026 due to swimming.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947276 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945043 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945041 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking due to perspiration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944455 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6)2026 where the infusion set tape was not sticking due to swimming.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944443 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape not sticking event due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944250 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape was not sticking after insertion event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944244 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an infusion set adhesive failure on (b)(6)2026, where the tape not sticking due to perspiration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944047 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape not sticking event due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944041 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943408 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that patient faced and event of infusion set tubing came apart after two days of use on (b)(6)2026. Insertion site was right arm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942826 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced tape detached due to hot weather condition on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942298 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935790 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935789 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935361 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935193 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an event on (b)(6) 2026 in which infusion set tape was not sticking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934401 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50930328 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929978 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929964 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced hyperglycemia event on (b)(6)2026 and was treated with manual injection.
Patient problems: Hyperglycemia
MAUDE report 50929948 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50923470 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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